Defense Department's AFIRM to fund Stratatech's Phase IIb clinical trial of StrataGraft tissue

Oct 8 2010

Stratatech Corp., a regenerative medicine company focused on the commercialization of cell-based, tissue-engineered skin substitute products, today announced that the Defense Department's Armed Forces Institute of Regenerative Medicine (AFIRM) will fund the Phase IIb clinical trial of the company's flagship StrataGraft^® living human skin substitute tissue.

“Stratatech is very pleased to be selected to receive this AFIRM funding, which will advance the clinical testing of our StrataGraft® tissue”

"Stratatech is very pleased to be selected to receive this AFIRM funding, which will advance the clinical testing of our StrataGraft^® tissue," said Lynn Allen-Hoffmann, Ph.D., Stratatech's founder, chief executive and chief scientific officer. "This phase of our StrataGraft^® clinical trial is a major step forward in our efforts to commercialize a product that should provide significant benefits to patients with severe burns, wounds and other traumatic skin injury. We look forward to working with our collaboration partners towards a successful clinical trial outcome."

Stratatech's clinical trial is one of only three trials selected nationally in 2010 by AFIRM for funding. AFIRM's funding of Stratatech's StrataGraft^® clinical trial totals $3.95 million. The company announced in April that it also had raised $3.0 million from its current investors to support the advancement of the clinical trial. The clinical trial is expected to start during the first half of 2011.

The goal of the Phase IIb trial is to assess the efficacy of StrataGraft^® tissue as a true skin substitute in the healing of excised, deep, partial-thickness burns that otherwise would require skin grafting. The successful completion of Phase IIb will move the company closer to regulatory submission, approval and commercialization of its StrataGraft^® product. During the previous Phase I/IIa clinical trial of its StrataGraft^® tissue, the company achieved its primary clinical endpoints, which related to the safety and early efficacy of the tissue in patients with third-degree burns and other complex skin defects. No adverse events were deemed to be associated with exposure to StrataGraft^® tissue in the Phase I/IIa trial.

"StrataGraft^® tissue is a very exciting technology, with promise to be a clinically-efficacious, off-the-shelf skin substitute," said James H. Holmes IV, M.D., professor of surgery at the Wake Forest University School of Medicine and the Wake Forest Institute of Regenerative Medicine (WFIRM), and medical director of the Wake Forest University Baptist Medical Center Burn Center. "The AFIRM funding is an indication of the Department of Defense's agreement with this outlook and represents its continued support of improved outcomes for our wounded warriors. The AFIRM trial is the next step on the path to demonstrating StrataGraft's clinical efficacy as a skin substitute and we anticipate exciting, positive results."

This multi-center clinical trial will be conducted as a collaboration between the U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas; the University of Wisconsin-Madison Hospital and Clinics, Madison, Wis.; Wake Forest University Baptist Medical Center, Winston-Salem, N.C.; and the Arizona Burn Center, Phoenix, Ariz.